This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publica...tions are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
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Regulation of the Minister of Health of the Republic of Indonesia on Prevention of HIV Transmission from Mother to Child
This Review summarizes many of the persistent biological alterations associated with childhood maltreatment including changes in neuroendocrine and neurotransmitter systems and pro-inflammatory cytokines in addition to specific alterations in brain areas associated with mood regulation. Finally, I d...iscuss several candidate gene polymorphisms that interact with childhood maltreatment to modulate vulnerability to major depression and PTSD and epigenetic mechanisms thought to transduce environmental stressors into disease vulnerability.
Neuron Review, vol. 89, March 2, 2016 pp.892-909
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Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epi...demic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO will expedite prequalification and licensing of the vaccine for use in countries at risk of Ebola outbreaks and will coordinate work between those countries’ regulatory authorities and the European Medicines Agency and the US Food and Drug Administration.
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In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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An Act to repeal the Dangerous Medicines Act of 1973,to ensure the availability of certain drugs for exclusive medical, scientific and related purposes, while preventing their abuse; to prevent the diversion from lawful trade of controlled chemicals, controlled equipment and controlled materials for... use in the unlawful manufacture of such drugs; to render drug trafficking and related conduct as serious criminal offences and to ensure that trafficking and related conducted as serious criminal offences and to ensure that offenders or suspects are brought to justice; to render certain conduct by drug users as criminal offences, to provide for the treatment and rehabilitation of drug abusing or dependent offenders; to establish the Lesotho Narcotics Bureau; and for related matters.
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World Drug Report 2018
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International Journal of Drug Policy 24 (2013) e91-98
Regulation of the Minister of Health of the Republic of Indonesia Number 5 Year 2014 about the Clinical Practice Guide for Physicians at Primary Health Care Facilities
Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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The occurrence of a high percentage of couterfeit medicines on the global medicines market is often attributed to a lack of effective regulation and a weak enforcement capacity. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information... on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world.
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The use of Delamanid and Bedaquiline for Children with Drug-Resistant Tuberculosis.
An Act to provide for the efficient and comprehensive regulation and control of food, drugs, medical devices, cosmetics, herbal drugs and poisons and to repeal the Food
(Control of Quality) Act, 1978, the Pharmaceuticals and Poisons Act, 1978 and to provide for related matters.
Global actions to reduce antimicrobial resistance (AMR) include optimising the use of antimicrobial medicines in human and animal health. In countries with weak healthcare regulation, this requires a greater understanding of the drivers of antibiotic use from the perspective of providers and consume...rs. In Bangladesh, there is limited research on household decision-making and healthcare seeking in relation to antibiotic use and consumption for humans and livestock. Knowledge is similarly lacking on factors influencing the supply and demand for antibiotics among qualified and unqualified healthcare providers. The aim of this study is to conduct integrated research on household decision-making for healthcare and antibiotic use, as well as the awareness, behaviours and priorities of healthcare providers and sellers of antibiotics to translate into policy development and implementation
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Antimicrobials have been a critical public health tool since the discovery of penicillin in 1928, saving the lives of millions of people around the world. Today, however, the emergence of drug resistance is reversing the miracles of the past eighty years, with drug choices for the treatment of many ...infections becoming increasingly limited, expensive, and, in some cases, non-existent.
Conscious of the public health threats of AMR to both humans, animals and the environment, the ministries of health and sanitation, agriculture forestry and food security and the environmental protection agency put together a national multi-sectoral coordinating group tasked with the responsibility of establishing mechanisms to integrate all initiatives into a single concerted action and development of the national AMR strategic plan (2018-2022). The National Strategic Plan on Antimicrobial Resistance is the first approach which addresses AMR specifically.
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The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis, ...Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact.
The document provides information on different aspects of care and support for TB patients. In particular, the handbook provides practical guidance on the implementation of the interventions that enable treatment adherence such as social support, treatment administration options, digital adherence technologies. The practical guidance also includes models of care for all TB patients, models of care for children and adolescents, integrated care for TB, HIV and comorbidities, engagement of private sector, managing of TB in health emergencies. This new practical handbook also includes two important chapters on health education and counselling, and palliative care for patients with TB.
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The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug... Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
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This document shall serve as the most comprehensive set of guidelines on the safe management of waste generated from heath care activities in the country. It incorporates the requirements of all Philippine laws and regulations governing HCWM and is designed for the use of individuals, public and pri...vate establishments, and other entities involved in segregation, collection, handling, storage, treatment,and disposal of waste generated from heath care activities.
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Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug products for individual patients. Included in this document is information on facilities and equipment, ingredient... selection, training, documentation and record keeping, stability and beyond-use dating, packaging and labeling, and limited batch compounding. This document is not intended for manufacturers or licensed repackagers.
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